Biotech Values

[Biowatch]

RDTs when companies don't know a biomarker...

Dew:

mediocre design that companies fall back on when they don’t know how to enrich a phase-2 trial with a biomarker...

iwfal:

part of any ph ii RDT had better be an exhaustive search for a biomarker. Either that or some way to prove that in the group for whom it is not efficacious that there are no excess deaths in the treated population...

Well, what if there is no known or reliable or proven biomarker?

biomaven:

To my knowledge [RDTs have] only ever been used in a Phase II and I can't imagine the FDA accepting one as a pivotal trial...

So the bottom line is that without a reasonable explanation for this approach, it's hokus-pokus?

Biostaticians on FDA Advisory panels probably agree. Although if it's an investor's favorite stock, that opinion is often discounted.

RDT = randomized-discontinuation trial